BEUDAMED
    FDA Enforcement Class II Terminated

    MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laboratory. I

    Recall: Z-1417-2021 · Reported April 21, 2021

    Enforcement

    Recall Number
    Z-1417-2021
    Event ID
    87575
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vectornate USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 21, 2021
    Initiation Date
    February 16, 2021
    Classification Date
    April 13, 2021
    Termination Date
    December 8, 2022
    Address
    10 Industrial Ave Ste 4, N/A, Mahwah, NJ, 07430-2284, United States

    Description

    MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laboratory. I

    Reason

    Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.

    Code Info

    Serial #: STM-UNV-0001-Q121, Lot #: JAH161, KAG076

    Distribution

    US Nationwide distribution in the state of NJ.

    Quantity

    130,000 devices